Cleared Traditional

K041635 - G5 I HBA1C TEST

K041635 is the FDA 510(k) clearance for G5 I HBA1C TEST by Provalis Diagnostics , Ltd.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K041635 · Provalis Diagnostics , Ltd. · Chemistry device
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Aug 2004
Decision
61d
Days
Class 2
Risk

K041635 is an FDA 510(k) clearance for the G5 I HBA1C TEST, G5 II HBA1C TEST. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Provalis Diagnostics , Ltd. (Rockville, US). The FDA issued a Cleared decision on August 16, 2004 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Provalis Diagnostics , Ltd. devices

Submission Details

510(k) Number K041635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date August 16, 2004
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K041635.
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459 · Beckman Coulter, Inc. · Nov 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
K042193 · Diazyme Laboratories · Oct 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
K041764 · Ortho-Clinical Diagnostics · Sep 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · Bio-Rad Laboratories, Inc. · Jun 2004
VARIANT II HEMOGLOBIN A1C
K040872 · Bio-Rad Laboratories, Inc. · Apr 2004
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
K031380 · Olympus America, Inc. · Nov 2003